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Completed

NCT Number: NCT02837575

Safety and Efficacy Study of Herpes Simplex Virus Type 2 (HSV-2) Therapeutic DNA Vaccine

The purpose of this trial is to evaluate the safety and efficacy of a therapeutic DNA vaccine in adults with symptomatic herpes simplex virus type 2 (i.e., genital herpes).

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Key information

Conditions

Herpes Genitalis Communicable Diseases DNA Virus Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Herpes Simplex Herpesviridae Infections Infections Male Urogenital Diseases Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Urogenital Diseases Virus Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Alabama Vaccine Research Clinic at University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

To evaluate the safety and efficacy of 4 doses of VCL-HB01, a therapeutic HSV plasmid DNA vaccine formulated with Vaxfectin® in HSV-2-seropositive adults with a reported history of symptomatic genital herpes for at least one year.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HSV-2 seropositive
  • A minimum of 1 year of reported history of genital herpes with recurrences.

Exclusion criteria

  • History of receiving an investigational HSV vaccine
  • Chronic illness for which a subject's immune system is suspected to be impaired or altered, such as cancer, autoimmune conditions, or diabetes
  • Pregnant or breastfeeding

Treatment and study plan

VCL-HB01

Biological

Investigational Product

Phosphate-buffered saline

Other

Placebo

Other names: PBS

Primary outcomes

  1. Lesion recurrences

    Time frame: Up to Day 450

Secondary outcomes

  1. Number of participants with adverse events

    Time frame: Up to Day 450

  2. Time to first recurrence

    Time frame: Up to Day 450

  3. Proportion of subjects recurrence-free

    Time frame: Up to Day 450

Sponsors and collaborators

Lead sponsor

Vical

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Safety and Efficacy of Herpes Simplex Virus, Type 2 (HSV-2) Therapeutic DNA Vaccine in Adults With Symptomatic Genital HSV-2 Infection

Acronym: HSV-2

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 19, 2016
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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